Human Subjects Review (HSR)

Physical Risk

In general, no human subjects research at Evergreen should exceed minimal risk for physical harm to participants. Here are three common types of study that present physical risks.

  • Exercise other than ordinarily encountered in daily life by that subject would be considered more than minimal risk. One must consider characteristics of potential research subjects as well as the type of exercise involved in the study. For example, walking a 50 foot hallway, for most healthy subjects, would be considered minimal risk. For the elderly, heart patients, or someone recovering from knee surgery, it might be considered more than minimal risk. Similarly, swimming 500 meters without rest for the general population would be considered more than minimal risk; for members of a high school varsity swim team, it might be considered minimal risk. Other kinds of risk associated with physical exercise include the potential for ergonomic-related or repetitive motion injuries (e.g., tendinitis or carpal tunnel syndrome).
  • Ingesting, tasting, smelling, or application of substances that pose any health risk are considered “more than minimal risk.” Ingestion or tasting projects that involve commonly available food or drink will be evaluated by the IRB who will determine risk level based upon the nature of study and local norms around food typically encountered in the research setting.
  • Be aware of potential risks to people suffering allergies, phobias, or environmental sensitivities. Examples might be such things as the peanuts often included in candies; mold and dust of a research space; flickering lights triggering epileptic seizures; public speaking or group testing for people with agoraphobia; small laboratory cubicles for people with claustrophobia. Identify any pertinent aspects on the consent statement, and clearly request individuals who have a sensitivity to these stimuli to exclude themselves from participating in the research.

Studies that collect physiological data or specimens should employ only non-invasive, minimal risk procedures. Contact the IRB administrator prior to developing any such proposed projects. For more details, see the federal Office for Human Research Protections’ guidance about minimal risk research activities.